Assistant Manager - Pharmaceutical Quality Assurance

Role & Responsibilities:

• Conduct third-party audits at client sites.
• Perform desk reviews of Quality Management System (QMS) documentation, including Batch Manufacturing Records (BMRs), Validation and Qualification protocols, and Standard Operating Procedures (SOPs).
• Provide comprehensive solutions for identified gaps or deficiencies during the review process.
• Ensure compliance with regulatory requirements and client standards.

Preferred Candidate Profile:

• Expertise in handling Quality Management Systems.
• Skilled in reviewing Risk Assessments and investigation reports.
• Experience in analyzing and reviewing analytical data.
• Proficient in conducting third-party audits and preparing compliance reports.
• Competent in managing Corrective Action & Preventive Action (CAPA) processes.
• Well-versed in Process Validation, Cleaning Validation, and Analytical Method Validation.
• Excellent technical writing skills for documentation and reporting.
• Knowledgeable about the latest regulatory guidelines and standards.
• Willingness to travel across India for client visits.
• Flexible to work additional hours as needed.
• Proficient in Microsoft Office tools.